BACKGROUND: The influence of indications for Helicobacter pylori investigation on prescriptions and effectiveness is unknown. The aim of the study was to assess the impact of indications for H. pylori investigation on prescriptions, effectiveness, compliance, and tolerance.
METHODS: International, prospective, non-interventional registry of the management of H. pylori infection by European gastroenterologists (Hp-EuReg). Treatment-näive patients registered from 2013 to 2023 at e-CRF AEG-REDCap were analyzed. The effectiveness was assessed by modified intention-to-treat analysis.
RESULTS: Overall, 53,636 treatment-naïve cases from 34 countries were included. Most frequent indications were: dyspepsia with normal endoscopy (49%), non-investigated dyspepsia (20%), duodenal ulcer (11%), gastric ulcer (7.7%), and gastroesophageal reflux disease (GERD) (2.6%). Therapy effectiveness varied by indication: duodenal ulcer (91%), gastric ulcer (90%), preneoplastic lesions (90%), dyspepsia with normal endoscopy (89%), GERD (88%), and non-investigated dyspepsia (87%). Bismuth-metronidazole-tetracycline and clarithromycin-amoxicillin-bismuth quadruple therapies achieved 90% effectiveness in all indications except GERD. Concomitant clarithromycin-amoxicillin-tinidazole/metronidazole reached 90% cure rates except in patients with non-investigated dyspepsia; whereas sequential clarithromycin-amoxicillin-tinidazole/metronidazole proved optimal (≥90%) in patients with gastric ulcer only. Adverse events were higher in patients treated for dyspepsia with normal endoscopy and duodenal ulcer compared with the remaining indications (23% and 28%, p < 0.001). Therapeutic compliance was higher in patients with duodenal ulcer and preneoplastic lesions (98% and 99%, p < 0.001).
CONCLUSIONS: In Europe, patients with gastric or duodenal ulcers and preneoplastic lesions showed higher H. pylori treatment effectiveness. Bismuth and non-bismuth quadruple therapies achieved optimal results in almost all indications.
BACKGROUND: ClinicalTrials.gov identifier: NCT02328131.

A previous short time span study related to the effectiveness of a teaching pack (TP) in improving the adherence to the Mediterranean Diet (MD) showed positive results. The present study was aimed at investigating and confirming those results, with a follow up data collection, in the same sample, a year after the baseline intervention. Pre- and post-intervention assessments were conducted. Weight and height were measured. Eating patterns/lifestyle were assessed by the KIDMED test and questionnaires. Thirteen schools in three areas with low, medium and high prevalence of overweight/obesity (North, Center and South respectively) were involved, with a representative baseline cluster sample of 494 fourth class children (8-10 years old) in 2015. An intervention group and a control group were recruited in each school; the intervention group (n = 395) got the intervention, the control group (n = 99) did not. The children\'s KIDMED score changes were the main outcome measures. Differences in percentages of adherence and in yes/no answers on the KIDMED test, at baseline and after one year, for both the intervention and the control groups, were assessed through contingency tables and statistical tests. Improvements in the high and low adherence rates to MD were observed (high adherence: 24.4% to 43.3%; low adherence: 15.0% to 3.9%, p < 0.0001). The percentages of subjects with optimal adherence improved in both sexes (females: 25.5% to 49.5%, p < 0.0001; males: 23.1% to 36.6%, p < 0.0001) in all the geographical areas and ponderal status classes. Accompanying free distribution of fruit and vegetables with a nutritional intervention led by trained teachers with a cross-curricular approach can be successful in promoting healthy eating in children.

OBJECTIVE: Continuous positive airway pressure (CPAP) is the primary therapy for obstructive sleep apnea (OSA); however the effectiveness of CPAP remains suboptimal. We describe the Novel PhysIologiC prEdictors of Positive Airway Pressure Effectiveness (NICEPAP) study. Its purpose is to determine whether physiological traits of OSA contribute to CPAP effectiveness.
METHODS: NICEPAP (NCT05067088) is a prospective, observational cohort study conducted at an academic sleep center. Adults newly diagnosed with OSA (n = 267) are assessed for OSA traits of loop gain, arousal threshold, pharyngeal collapsibility, and muscle compensation from baseline polysomnography. We perform a comprehensive assessment of covariates relevant to CPAP adherence, efficacy, and patient-centered outcomes. Participants are followed for 12 months. Primary outcomes include (1) CPAP adherence (hours/night), (2) CPAP efficacy (apneas-hypopneas/hour), and (3) quality of life at six months measured by objective CPAP data and Functional Outcomes of Sleep Questionnaire. Secondary outcomes include sleep quality, sleepiness, insomnia, and neurocognitive function.
RESULTS: Data on covariates, including demographics, sleep symptoms, medical history, medications, sleep quality, OSA and treatment self-efficacy, decisional balance, and socio-economic and social and partner support, are collected using validated instruments. The analysis for primary outcomes includes a generalized linear mixed model for an outcome (e.g., CPAP adherence) with OSA traits as exposures followed by the addition of relevant covariates.
CONCLUSIONS: The findings of the NICEPAP study will inform research aimed to enhance CPAP effectiveness. Understanding the role of physiological OSA traits in CPAP effectiveness is a crucial step toward a precision medicine approach to OSA.

UNASSIGNED: Use of tele-technology for monitoring symptoms, functional parameters and quality of life of people with asthma is essential. Delivering this information among patients is mandated for a better outcome are made possible via patient education (PE). This review aims to summarise the types of telerehabilitation modalities dosage, outcome measures used to assess the effectiveness of PE among people with asthma.
UNASSIGNED: We adopted a scoping review methodology. Thematic analysis was used to synthesize the data. The Preferred Reporting System for Meta-Analysis for Scoping Reviews was followed during the review process (PRISMA-ScR).
UNASSIGNED: PubMed, Embase, and Scopus were searched with thirty-four studies meeting inclusion criteria. Results were presented in three themes: telerehabilitation platforms used to deliver PE among patients with asthma; content, duration and frequency of the PE administered; patient-reported outcome measures used to evaluate the effectiveness of PE.
UNASSIGNED: This scoping study detailed the types of telerehabilitation modalities, dosage, and outcome measures used to assess the effectiveness of PE in people with asthma. This review will be especially beneficial to those considering where additional research or implementation of telerehabilitation for asthma patients is required. The studies emphasized the involvement of several healthcare experts, emphasizing the significance of a multidisciplinary approach to efficient PE delivery and possible improvements in asthma management through telerehabilitation. Although a range of telerehabilitation platforms were generally accepted, hybrid models that integrate online and in-person sessions could further enhance patient satisfaction and quality of life. Comprehensive economic analyses are also required, and solving technology issues is essential to maximizing the efficacy of these initiatives.

UNASSIGNED: Psychological first aid (PFA) is essential for mental health and wellbeing after traumatic events. Integrating competency-based outcomes is crucial with the increasing demand for effective psychological first-aid interventions. This study examines the correlation between sustainability competencies and PFA principles within Fiji\'s disaster responder\'s context.
UNASSIGNED: The research was guided by a theoretical framework based on a comprehensive review of sustainability competencies and PFA principles. A cross-sectional survey assessed the importance of sustainability competencies in disaster responders to deliver PFA effectively. The survey used a stratified random sampling method to get diverse PFA-trained participants (66%) and non-PFA trained (34%), aiming to understand how these competencies can impact PFA success in various disaster situations. The survey, encompassing various domains of disaster response and a diverse range of respondents age, gender, and years of experience, employed the Likert scale to assess the importance of competencies such as integrated problem-solving, strategic, systems thinking, self-awareness, normative, collaboration, anticipatory, and critical thinking.
UNASSIGNED: The study involved 49 PFA-trained participants (55% female, 45% male) and 15 non-PFA-trained participants (53% female, 46% male), excluding 10 responses from the latter group due to ambiguous answers to critical questions. The correlation between age, experience, and the valuation of professional competencies among disaster responders indicates that disaster responders, with extensive experience and PFA training, rated competencies as \"important,\" reflecting a perspective shaped by long-term career development and practical experiences. Equally, younger and early career responders emphasize competencies as \"very important,\" indicating an initial recognition of their significance. The appraisal patterns across different age groups, especially among those with PFA training, suggest a tendency to moderate assessments of competency importance with increasing experience. Statistical analysis, including mean, median, standard deviation, and variance, provided a detailed understanding of the data, underscoring competencies like self-awareness in both data sets and integrated problem-solving and collaboration within PFA-trained responders as the key for effective PFA interventions.
UNASSIGNED: The study underlines the critical need to integrate sustainability competencies into the PFA curriculum in Fiji\'s unique sociocultural context. This interplay between age, experience, and competency assessment stresses the diverse factors influencing perceptions in the disaster response field beyond experience alone. The results show that sustainability competencies are the ultimate to the effectiveness of PFA measurement and interventions. The research lays the foundation for future studies to develop validated tools for assessing sustainable competencies in different cultural contexts, thereby improving the effectiveness of PFA in disaster management. Integrating these competencies into PFA training could significantly strengthen PFA intervention and competency-based evaluation.

BACKGROUND: In the treatment of borderline personality disorder (BPD), there is empirical support for both dialectical behavior therapy (DBT) and schema therapy (ST); these treatments have never been compared directly. This study examines whether either of them is more effective than the other in treating patients with BPD.
METHODS: In this randomized, parallel-group, rater-blind clinical trial, outpatients aged between 18 and 65 years with a primary diagnosis of BPD were recruited in a tertiary outpatient treatment center (Lübeck, Germany). Participants were randomized to DBT or ST with one individual and one group session per week over 1.5 years. The primary outcome was the BPD symptom severity assessed with the mean score of the Borderline Personality Disorder Severity Index at 1-year naturalistic follow-up.
RESULTS: Between November 26, 2014, and December 14, 2018, we enrolled 164 patients (mean age = 33.7 [SD = 10.61] years). Of these, 81 (49.4%) were treated with ST and 83 (50.6%) with DBT, overall, 130 (79.3%) were female. Intention-to-treat analysis with generalized linear mixed models did not show a significant difference at 1-year naturalistic follow-up between DBT and ST for the BPDSI total score (mean difference 3.32 [95% CI: -0.58-7.22], p = 0.094, d = -24 [-0.69; 0.20]) with lower scores for DBT. Pre-to-follow-up effect sizes were large in both groups (DBT: d = 2.45 [1.88-3.02], ST: d = 1.78 [1.26-2.29]).
CONCLUSIONS: Patients in both treatment groups showed substantial improvements indicating that even severely affected patients with BPD and various comorbid disorders can be treated successfully with DBT and ST. An additional non-inferiority trial is needed to show if both treatments are equally effective. The trial was retrospectively registered on the German Clinical Trials Register, DRKS00011534 without protocol changes.

BACKGROUND: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality and transarterial chemoembolisation (TACE) is an established technique to treat patients with intermediate-stage HCC. The aim of this study was to generate accurate costing data on cTACE and DEB-TACE in an Australian setting and assess whether one of the procedures offers favourable cost-effectiveness.
METHODS: Costing study using data from all TACE procedures performed at a single centre between January 2018 and December 2022. Data were included from all direct and indirect costs including operative costs, wages, overheads, ward costs, transfusion, pathology, pharmacy and ward support. Cost-effectiveness was assessed by dividing local costs by existing high-quality data on quality-adjusted life years (QALYs).
RESULTS: 64 TACE treatments were performed on 44 patients. Mean age was 66.5 years and 91% were male. Overall median total cost per patient for the entire TACE treatment regime was AUD$7380 (range AUD$3719-$20,258). However, 39% of patients received more than one treatment, and the median cost per individual treatment was AUD$5270 (range AUD$3533-$15,818). The difference in median cost between cTACE (AUD$4978) and DEB-TACE (AUD$9202) was significant, P < 0.001. In calculating cost-effectiveness, each cTACE treatment cost AUD$2489 per QALY gained, while each DEB-TACE cost AUD$3834 per QALY gained. The incremental cost-effectiveness ratio (ICER) for DEB-TACE over cTACE was AUD$10,560 per QALY gained.
CONCLUSIONS: Both cTACE and DEB-TACE are low-cost treatments in Australia. However, DEB-TACE offers a solution with an ICER of AUD$10,560 per QALY gained which is below the Australian government willingness to pay threshold and thus is a more cost-effective treatment.

BACKGROUND: Finerenone, a non-steroidal mineralocorticoid receptor antagonist, has previously demonstrated its efficacy and safety in chronic kidney disease (CKD) associated with diabetes mellitus. Given its therapeutic potential, finerenone has been preliminarily explored in clinical practice for non-diabetic CKD patients. The effectiveness and safety in this population require further investigation in a real-world setting.
METHODS: This retrospective, real-world analysis included non-diabetic CKD patients receiving finerenone. The main clinical outcomes assessed were changes in urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR). Serum potassium (sK+) levels were also monitored. Data were collected at baseline, and then at 1 month and 3 months following treatment initiation.
RESULTS: Totally, 16 patients were included. There was a notable decrease in UACR from 1-month post-treatment, with a further reduction at 3 months, resulting in a median reduction of 200.41 mg/g (IQR, 84.04-1057.10 mg/g; P = 0.028; percent change, 44.52% [IQR, 31.79-65.42%]). The average eGFR at baseline was 80.16 ml/min/1.73m2, with no significant change after 1 month (80.72 ml/min/1.73m2, P = 0.594) and a slight numerical increase to 83.45 ml/min/1.73m2 (P = 0.484) after 3 months. During the 3-month follow-up, sK+ levels showed only minor fluctuations, with no significant differences compared to baseline, and remained within the normal range throughout the treatment period. No treatment discontinuation or hospitalization due to hyperkalemia was observed.
CONCLUSIONS: In non-diabetic CKD patients, finerenone showed good effectiveness and safety within a 3-month follow-up period. This study provides valuable real-world evidence supporting the use of finerenone in non-diabetic CKD and highlights the need for future large-scale prospective research to further validate its efficacy.

OBJECTIVE: There is currently no reliable tool for classifying dementia severity level based on administrative claims data. We aimed to develop a claims-based model to identify patients with severe dementia among a cohort of patients with dementia.
METHODS: Retrospective cohort study.
METHODS: We identified people living with dementia (PLWD) in US Medicare claims data linked with the Minimum Data Set (MDS) and Outcome and Assessment Information Set (OASIS).
METHODS: Severe dementia was defined based on cognitive and functional status data available in the MDS and OASIS. The dataset was randomly divided into training (70%) and validation (30%) sets, and a logistic regression model was developed to predict severe dementia using baseline (assessed in the prior year) features selected by generalized linear mixed models (GLMMs) with least absolute shrinkage and selection operator (LASSO) regression. We assessed model performance by area under the receiver operating characteristic curve (AUROC), area under precision-recall curve (AUPRC), and precision and recall at various cutoff points, including Youden Index. We compared the model performance with and without using Synthetic Minority Oversampling Technique (SMOTE) to reduce the imbalance of the dataset.
RESULTS: Our study cohort included 254,410 PLWD with 17,907 (7.0%) classified as having severe dementia. The AUROC of our primary model, without SMOTE, was 0.81 in the training and 0.80 in the validation set. In the validation set at the optimized Youden Index, the model had a sensitivity of 0.77 and specificity of 0.70. Using a SMOTE-balanced validation set, the model had an AUROC of 0.83, AUPRC of 0.80, sensitivity of 0.79, specificity of 0.74, positive predictive value of 0.75, and negative predictive value of 0.78 when at the optimized Youden Index.
CONCLUSIONS: Our claims-based algorithm to identify patients living with severe dementia can be useful for claims-based pharmacoepidemiologic and health services research.

The 4-component meningococcal serogroup B (MenB) vaccine, 4CMenB, the first broadly protective, protein-based MenB vaccine to be licensed, is now registered in more than 50 countries worldwide. Real-world evidence (RWE) from the last decade confirms its effectiveness and impact, with infant immunization programs showing vaccine effectiveness of 71-95% against invasive MenB disease and cross-protection against non-B serogroups, including a 69% decrease in serogroup W cases in 4CMenB-eligible cohorts in England. RWE from different countries also demonstrates the potential for additional moderate protection against gonorrhea in adolescents. The real-world safety profile of 4CMenB is consistent with prelicensure reports. Use of the endogenous complement human serum bactericidal antibody (enc-hSBA) assay against 110 MenB strains may enable assessment of the immunological effectiveness of multicomponent MenB vaccines in clinical trial settings. Equitable access to 4CMenB vaccination is required to better protect all age groups, including older adults, and vulnerable groups through comprehensive immunization policies.
Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis(meningococcus), is rare but often devastating and can be deadly. Effective vaccines are available, including vaccines against meningococcal serogroup B disease. In 2013, the 4-component meningococcal serogroup B vaccine, 4CMenB, became the first broadly protective, protein-based vaccine against serogroup B to be licensed, with the second (bivalent vaccine, MenB-FHbp) licensed the following year. 4CMenB is now registered in more than 50 countries, in the majority, for infants and all age groups. In the US, it is approved for individuals aged 10–25 years. Evidence from immunization programs in the last decade, comparing vaccinated and unvaccinated individuals and the same population before and after vaccination, confirms the effectiveness and positive impact of 4CMenB against serogroup B disease. This also demonstrates that 4CMenB can provide protection against invasive diseases caused by other meningococcal serogroups. Furthermore, N. meningitidis is closely related to the bacterium that causes gonorrhea, N. gonorrhoeae, and emerging real-world evidence suggests that 4CMenB provides additional moderate protection against gonococcal disease. The safety of 4CMenB when given to large numbers of infants, children, adolescents, and adults is consistent with the 4CMenB safety profile reported before licensure.For the future, it would be beneficial to address differences among national guidelines for the recommended administration of 4CMenB, particularly where there is supportive epidemiological evidence but no equitable access to vaccination. New assays for assessing the potential effectiveness of meningococcal serogroup B vaccines in clinical trials are also required because serogroup B strains circulating in the population are extremely diverse across different countries.